药品注册申请号：018415
申请类型：NDA (新药申请)
申请人：ESJAY PHARMA
申请人全名：ESJAY PHARMA LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG No No AB 1982/07/27 1982/07/27 Prescription
002 FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG No No AB 1982/07/27 Prescription
003 FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG No No AB 1984/11/26 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1982/07/27 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2022/09/16 SUPPL-28（补充） Approval Labeling-Package Insert STANDARD
2014/10/01 SUPPL-26（补充） Approval Labeling STANDARD
1999/06/08 SUPPL-24（补充） Approval Manufacturing (CMC)
1995/11/14 SUPPL-23（补充） Approval Manufacturing (CMC)
1993/06/30 SUPPL-21（补充） Approval Manufacturing (CMC)
1993/04/01 SUPPL-22（补充） Approval Labeling
1992/03/26 SUPPL-20（补充） Approval Labeling
1989/08/09 SUPPL-19（补充） Approval Manufacturing (CMC)
1989/08/09 SUPPL-18（补充） Approval Manufacturing (CMC)
1988/11/04 SUPPL-17（补充） Approval Manufacturing (CMC)
1988/11/04 SUPPL-15（补充） Approval Labeling
1988/11/04 SUPPL-14（补充） Approval Manufacturing (CMC)
1988/11/04 SUPPL-13（补充） Approval Manufacturing (CMC)
1988/11/04 SUPPL-12（补充） Approval Manufacturing (CMC)
1987/03/17 SUPPL-8（补充） Approval Manufacturing (CMC)
1986/11/06 SUPPL-11（补充） Approval Manufacturing (CMC)
1986/11/06 SUPPL-9（补充） Approval Manufacturing (CMC)
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
>>>活性成分:FUROSEMIDE; 剂型/给药途径:TABLET;ORAL; 规格:20MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018487 001 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Discontinued No No AB Approved Prior to Jan 1, 1982 PHARMOBEDIENT
018569 002 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB Approved Prior to Jan 1, 1982 EPIC PHARMA LLC
016273 002 NDA LASIX FUROSEMIDE TABLET;ORAL 20MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
018415 001 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 1982/07/27 ESJAY PHARMA
018823 001 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 1983/11/10 HIKMA
076796 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2004/03/26 PRINSTON INC
077293 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2005/11/09 LEADING
078010 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2006/09/18 IPCA LABS LTD
216629 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2022/10/17 GRAVITI PHARMS
218831 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 20MG Prescription No No AB 2025/07/17 AUROBINDO PHARMA LTD
>>>活性成分:FUROSEMIDE; 剂型/给药途径:TABLET;ORAL; 规格:40MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018487 002 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Discontinued No No AB Approved Prior to Jan 1, 1982 PHARMOBEDIENT
018569 001 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB Approved Prior to Jan 1, 1982 EPIC PHARMA LLC
016273 001 NDA LASIX FUROSEMIDE TABLET;ORAL 40MG Prescription Yes No AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
018415 002 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 1982/07/27 ESJAY PHARMA
018823 002 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 1983/11/10 HIKMA
076796 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2004/03/26 PRINSTON INC
077293 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2005/11/09 LEADING
078010 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2006/09/18 IPCA LABS LTD
216629 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2022/10/17 GRAVITI PHARMS
218831 002 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 40MG Prescription No No AB 2025/07/17 AUROBINDO PHARMA LTD
>>>活性成分:FUROSEMIDE; 剂型/给药途径:TABLET;ORAL; 规格:80MG; 治疗等效代码:AB<<<
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
016273 003 NDA LASIX FUROSEMIDE TABLET;ORAL 80MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 VALIDUS PHARMS
018569 005 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 1984/08/14 EPIC PHARMA LLC
018415 003 NDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 1984/11/26 ESJAY PHARMA
070086 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 1986/01/24 HIKMA
070082 001 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Discontinued No No AB 1986/10/29 PHARMOBEDIENT
076796 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2004/03/26 PRINSTON INC
077293 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2005/11/09 LEADING
078010 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2006/09/18 IPCA LABS LTD
216629 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2022/10/17 GRAVITI PHARMS
218831 003 ANDA FUROSEMIDE FUROSEMIDE TABLET;ORAL 80MG Prescription No No AB 2025/07/17 AUROBINDO PHARMA LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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